Artemisinin-based combination therapy during pregnancy: outcome of pregnancy and infant mortality: a cohort study.
Michael NamboziHalidou TintoVictor MwapasaHarry TagborJean-Bertin Bukasa KabuyaSebastian HachizovuMaminata TraoréInnocent ValeaMarc Christian TahitaGifty AmpofoJozefien BuyzeRaffaella RavinettoDiana ArangoKamala ThriemerModest MulengaJean-Pierre van GeertruydenUmberto D AlessandroPublished in: Malaria journal (2019)
Outcome of pregnancy and infant survival were similar between treatment arms indicating that any of the four artemisinin-based combinations could be safely used during the second and third trimester of pregnancy without any adverse effect on the baby. Nevertheless, smaller safety differences between artemisinin-based combinations cannot be excluded; country-wide post-marketing surveillance would be very helpful to confirm such findings. Trial registration ClinicalTrials.gov, NCT00852423, Registered on 27 February 2009, https://clinicaltrials.gov/ct2/show/NCT00852423.
Keyphrases
- combination therapy
- preterm birth
- pregnancy outcomes
- plasmodium falciparum
- public health
- computed tomography
- pregnant women
- gestational age
- study protocol
- randomized controlled trial
- emergency department
- type diabetes
- phase iii
- risk factors
- positron emission tomography
- coronary artery disease
- open label
- dual energy
- phase ii
- adverse drug
- placebo controlled